Affimed

In August 2013, LLS began its first European partnership with Affimed and supported three clinical trials for patients with Hodgkin lymphoma (HL) and Peripheral T-cell Lymphoma (PTCL). Expanding upon the initial work supported by LLS TAP, Affimed is currently enrolling "Bispecific NK Engager AFM13 Combined With NK Cells for Patients With Recurrent of Refractory CD30 Positive Hodgkin or Non-Hodgkin Lymphomas." AFM13 is bispecific tetravalent Innate Cell Engager targeting CD30 on tumor cells and CD16A on NK cells and macrophages. 

Affimed is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The company’s proprietary ROCK® platform enables a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors, enabling a broad pipeline of wholly-owned and partnered single agent and combination therapy programs. The ROCK platform predictably generates customized innate cell engager (ICE®) molecules, which use patients’ immune cells to destroy tumor cells.

LLS TAP has supported clinical development of AFM13 in several clinical trials that have completed enrollment:

• GHSG-AFM13 An Open-label, Randomized, Multicenter Phase II Trial With AFM13 in Patients With Relapsed or Refractory Hodgkin Lymphoma (NCT02321592)
• A Phase 1b Dose Escalation Study to Assess the Safety of AFM13 in Combination With Pembrolizumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (NCT02665650)
• A Phase II Open-label Multicenter Study to Assess the Efficacy and Safety of AFM13 in Patients With Relapsed or Refractory CD30-positive Peripheral T-cell Lymphoma or Transformed Mycosis Fungoides (REDIRECT, NCT04101331)

Building on the initial work supported by LLS TAP and the success of the trials in CD30-positive lymphomas, the company recently completed a trial in partnership with MD Anderson Cancer Center entitled "Bispecific NK Engager AFM13 Combined With NK Cells for Patients With Recurrent of Refractory CD30 Positive Hodgkin or Non-Hodgkin Lymphomas" (NCT04074746).

AFM13 in combination with AB-101 (allogeneic natural killer cells) is currently in a Phase 2 clinical trial in relapsed or refractory Hodgkin lymphoma or CD30-positive PTCL that could eventually lead to commercialization (LuminICE-203, NCT05883449).

For more information about Affimed, visit www.affimed.com.

Recent News

• September 12, 2023 - announced that the FDA has granted fast track designation to the combination of AFM13 with AlloNK^® for the potential treatment of relapsed/refractory (r/r) Hodgkin lymphoma (HL). 
• May 23, 2023 - announced FDA has cleared IND application for the combination of AFM13 and AB-101 (off-the shelf, non-genetically modified, allogeneic cord blood-derived natural killer cells) to initiate the Phase 2 clinical trial, AFM13-203 (LuminICE-203) in Q3 2023
• April 17, 2023 - presented final clinical data of AFM13 Phase 2 REDIRECT study in patients with R/R PTCL at the AACR Annual Meeting
• January 9, 2023 - announced that Affimed remains on track to submit an IND in the first half of 2023 and to initiate a clinical study later in 2023 for the AFM13 and AB-101 co-administered combination therapy in r/r HL and an exploratory arm evaluating the combination in r/r CD30-positive PTCL.
• December 10, 2022 - data update at ASH from the ongoing phase 1/2 study of AFM13 precomplexed with cord blood-derived natural killer (cbNK) cells in patients with CD30-positive relapsed or refractory Hodgkin and Non-Hodgkin lymphomas.
• November 3, 2022 - announced a new strategic partnership to jointly develop, manufacture, and commercialize a combination therapy comprised of Affimed’s Innate Cell Engager AFM13 and Artiva’s cord blood-derived, cryopreserved off-the-shelf allogeneic NK cell product candidate, AB-101.